UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Fundamentals of molecular targeted therapy for primary central nervous system lymphoma based on genomic alterations
Title of the study (Brief title)	Genomic alterations in CNS lymphoma
Region	Japan

Condition
Condition	primary central nervous system lymphoma
Classification by specialty	Hematology and clinical oncology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Identify primary CNS lymphoma specific genomic alterations and construct fundamentals of molecular therapy based on the genomic alterations
Basic objectives2	Others
Basic objectives -Others	More than 50 cases of primary CNS lymphoma are collecetd for analysis of genomic alterations
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Identify primary CNS lymphoma specific genomic alterations. Among them, find molecular target for development and progression of lymphoma
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Brain tumor tissue obtained at stereotactic and craniotomy operation by skillful neurosurgeons. 2. Two parts of brain tumor tissue, one is for pathological diagnosis (formalin fixation) and another is for genomic analysis (frozen tissue). 3. Pathological diagnosis is primary CNS lymphoma
Key exclusion criteria	nothing particular
Target sample size	50

Research contact person
Name of lead principal investigator	Shingo Takano
Organization	Faculty of Medicine, University of Tsukuba
Division name	Department of Neurosurgery
Address	1-1-1 Tennoudai, Tsukuba city, Ibaraki 305-8575
TEL	029-853-3220
Email	shingo4@md.tsukuba.ac.jp

Public contact
Name of contact person	Shingo Takano
Organization	Faculty of Medicine, University of Tsukuba
Division name	Department of Neurosurgery
Address	1-1-1 Tennoudai, Tsukuba city, Ibaraki 305-8575
TEL	029(853)3220
Homepage URL
Email	shingo4@md.tsukuba.ac.jp

Sponsor
Institute	Department of Neurosurgery, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization	Department of Neurosurgery, Faculty of Medicine, University of Tsukuba
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Consortium for Brain Tumor Treatment
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 07 Month 21 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2010 Year 05 Month 24 Day
Anticipated trial start date	2010 Year 07 Month 01 Day
Last follow-up date	2012 Year 07 Month 01 Day
Date of closure to data entry	2012 Year 07 Month 01 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Collect more than 50 samplas of primary CNS lymphoma from 14 institutions during two years. Lymphoma samples are amalysed for genomic analysis using high density SNP array and any mutations of whole sequence using second generation sequencer. Among the genomic alterations found, identify the target gene for molecular therapy for primary CNS lymphoma.

Management information
Registered date	2010 Year 07 Month 20 Day
Last modified on	2018 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004721